Consent Form for Humanitarian Use Devices (HUDs) and Treatment Use of Unapproved Drugs/Devices

Follow these standards when writing the consent form:

-Items in [square brackets] indicate action from you such as making a choice or inserting relevant information.

-Write out terms before using the acronym.

-Do not use abbreviations.

-If your protocol involves a drug, use the generic name (not the trade name).

-Use the term patient, not subject.

-Include page numbers.

NOTE: If genetic testing will be done as part of this treatment and results will be provided to the sponsor, include the required genetic language from themain clinical consent template. Please contact the IRB if you have questions.


IRB#: ______
Approval Date: ______ / MED. REC. NO._____
NAME_____
BIRTHDATE_____

Consent Form for Treatment Only

TITLE: [Give IND, IDE, or HDE number assigned by FDA]: [Give name of drug or device]

PHYSICIAN:Name, Degrees (503)-494-XXXX

TREATMENT TEAM:Name, Degrees (503)-494-XXXX

Name, Degrees (503)-494-XXXX

SUPPORTED BY: Use this heading instead of the sponsor heading to name the entity providing financial support only such as a free drug.

INTRODUCTION:

Your doctor has told you that you have [give diagnosis and lay definition]. Your doctor thinks that it would be best to treat this disorder with [give name of drug or device].

For Humanitarian Use Device (HUD), state: The FDA has approved this device for treating this condition.

For an unapproved drug or device, state: The Food and Drug Administration (FDA) has notapproved this [drug or device] for treating this condition. The use of the [drug/device] is experimental.

For an expanded access IND, state: This drug is being provided under an expanded access program. Expanded access, sometimes called "compassionate use," is the use of an investigational drug (a drug that is not approved by the FDA) outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. For more information about expanded access to investigational drugs, see the FDA website at:

PROCEDURES:

Explain procedures, even if standard of care, in lay language in chronological order.

RISKS AND DISCOMFORTS:

Explain the risks of the drug or device and the procedures, even if the procedures are standard of care, in lay language. You may wish to refer to OHSU’s research consent templates for wording to describe the risks of some common procedures.

ALTERNATIVES:

Other treatments for your condition include [give standard approved options. If there are none, so state. If some of the options are experimental, you may refer to them, but clearly inform the subject that their effectiveness is unproven.].

CONFIDENTIALITY:

All of the records related to your treatment will be placed in your medical record as usual. If there is a problem with your treatment (such as a side effect [or device failure, if applicable]), your doctor may be required to report the problem to the Institutional Review Board (IRB) at Oregon Health & Science University, [if applicable: the company that makes the drug/device], and the Food and Drug Administration (FDA). They may review and copy the parts of your medical record related to your treatment with this [drug/device]. No one else will be allowed to see your medical records unless permitted by law or unless you give permission.

COSTS:

For Humanitarian Use Device: You or your insurance will be responsible for the cost of all care associated with the procedure[s] and the device itself. It is possible that your insurance will not pay these costs even though the device is FDA approved for use in your condition. If that occurs, you will be responsible for all costs and these costs may be substantial.

For investigational drug or device if patient will be responsible for ALL costs: You or your insurance will be responsible for the cost of all care associated with the procedure[s] and the [device/drug] itself. It is possible that your insurance will not pay for the cost of the [include as applicable: drug, device, procedure to implant the device] because the [drug/device] is considered investigational. If that occurs, you will be responsible for all costs and these costs may be substantial.

For investigational drug or device if sponsor is providing free drug/device: The [drug/device] will be provided to you at no cost. You or your insurance company will be responsible for the remaining costs related to this treatment. You will be responsible for any costs your insurance does not cover. If you have any questions about these costs, or what out-of-pocket expenses you may be responsible for, contact your insurance company.

LIABILITY:

If you believe you have been injured or harmed while participating in this treatment and require immediate medical care, contact [treatment team info, if treatment involves physical risks that may be immediate provide a phone number that is available 24 hours a day].

If you are injured or harmed by the [drug(s), device(s) or procedures], you will be treated. OHSU [and the funder, if applicable][does/do] not offer any financial compensation or payment for the cost of medical care if you are injured or harmed as a result of participating in this treatment. Therefore, any medical care you need may be billed to you or your insurance. However, you are not prevented from seeking to collect compensation for injury related to negligence on the part of those involved in the treatment. Oregon law (Oregon Tort Claims Act (ORS 30.260 through 30.300)) may limit the dollar amount that you may recover from OHSU or its caregivers for a claim relating to care at OHSU, and the time you have to bring a claim.

If you have questions on this subject, please call the OHSU Research Integrity Office at (503) 494-7887.

PARTICIPATION:

Your participation in this treatment is voluntary. If you do start the treatment and later change your mind, you have the right to quit at any time. If you choose not to have this treatment or change your mind later, there will be no penalty or loss of benefits to which you are otherwise entitled, including being able to receive health care services or insurance coverage for services. Talk to your doctor if you want to stop the treatment. You may need additional medical care to ensure your safety.

We will give you any new information we learn during the course of the treatment that might change the way you feel about receiving the treatment.

[Name, phone number] has offered to answer any other questions you may have about this treatment.

Your signature below shows that you have read this form and agree to this treatment.

______

Patient’s signatureDate

Revised 3/26/2015 Page 1 of 4

MED. REC. NO.:______

NAME:______

Epic CSN (if applicable):______